OncoMatch/Clinical Trials/NCT07480213
Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Is NCT07480213 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including EB-DART-NK01 (DLL3/CD56 CAR-NK cells) and Lymphodepleting chemotherapy for small cell lung cancer (sclc).
Treatment: EB-DART-NK01 (DLL3/CD56 CAR-NK cells) · Lymphodepleting chemotherapy — This study is an open-label, multi-center, adaptive Phase 1/2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3/CD56, DLL3/GD2, and CD56/GD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D).
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: DLL3 any tested (testing required; no eligibility threshold specified)
Required: GD2 any tested (testing required; no eligibility threshold specified)
Required: NCAM1 any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage IV
Metastatic disease required
metastatic, extensive-stage, or unresectable
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated)
Cannot have received: gene-modified cellular therapy (CAR-T, CAR-NK)
Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months
Cannot have received: therapy directed against investigational target antigens
Exception: if it would confound safety/efficacy assessment
any prior therapy directed against the investigational target antigens if it would confound safety/efficacy assessment
Cannot have received: allogeneic hematopoietic stem cell transplant
Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease
Lab requirements
Blood counts
ANC ≥ 1.0 x10^9/L, platelets ≥ 75 x10^9/L
Kidney function
creatinine clearance ≥ 50 mL/min
Liver function
AST/ALT ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN
Cardiac function
clinically significant cardiovascular disease excluded (e.g., recent MI within 6 months, uncontrolled arrhythmia, LVEF < 45%)
Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC ≥ 1.0 x10^9/L, platelets ≥ 75 x10^9/L, creatinine clearance ≥ 50 mL/min, AST/ALT ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN). Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF < 45%) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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